TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF- bacitracin,neomycin,polymxin, pramoxine ointment 
Trifecta Pharmaceuticals USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Triple Antibiotic Ointment + Pain Relief

DRUG FACTS

Active Ingredient

Bacitracin 500 Units

Purpose

First Aid Antibiotic

Active Ingredient

Neomycin 3.5mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B 10,000 Units

Purpose

First Aid Antibiotic

Active Ingredient

Pramoxine HCL 10mg

Purpose

External Analgesic

Uses

First Aid to help prevent infection in minor:

Warnings

For external use only. Do not use:

Ask a Doctor before Use

Ask Doctor before use if you have:

Stop Use and ask a Doctor if:

Keep out of Reach of Children

If Swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information

Inactive Ingredient:

Light mineral oil, Petrolatum

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

triple antibiotic ointment PDP

TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF 
bacitracin,neomycin,polymxin, pramoxine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-030-011 in 1 BOX07/20/2017
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/20/2017
Labeler - Trifecta Pharmaceuticals USA (079424163)

Revised: 1/2023
Document Id: f276cc9f-388d-4fe7-e053-2995a90abc00
Set id: 54c1d306-dc3b-2885-e054-00144ff8d46c
Version: 4
Effective Time: 20230117
 
Trifecta Pharmaceuticals USA